Must Medical Device Subcomponent Manufacturers Perform IQs and OQs on Existing Equipment?

I work for a company that makes wafers for an ISO 13485-certified company, who in turn makes chips that go into medical devices. They are telling me that we MUST do IQs and OQs for our already-installed equipment. True? Please detail your responses. Thanks!

 

Seems a bit of a stretch to me. The requirement is that processes whose outputs are not (or cannot be) 100% verified need to be validated. (IQ and OQ are *means* to support the validation... which are usually followed by PQ but that whole structure is a different discussion). The rationale is that an unvalidated process may result in defects which are only realized once the product is in the field. I would think if you supplied bad wafers, the effects would be seen well before product gets in the field, but I can't say for sure.

If they feel that the outputs of that process are not 100% verified then, indeed, they may feel it necessary to require validation. You can either do the validation on your dime, require that they pay for the validation (it ain't cheap!), or accept that they may not be a customer.

 

Also note that the fact that they are already installed makes little difference, if they do decide to push the issue and require IQOQs.

As a medical device company, we decided to IQOQ all our equipment whether the process is 100% validated or not. We are currently working on performing all of the IQOQs on existing equipment.

PQs are only performed on the not 100% verified processes.